Designing and Validating Manufacturing Execution Systems (E04)

2 June
0.6 CEUs		 Working Agenda
Current as of 1 May 2008
Download Working Agenda  PDF, 21 KB 

Sought after and backed by major pharmaceutical industry corporations worldwide, the concept of Manufacturing Execution Systems (MES) is now considered an enterprise approach to manufacturing. If your company is not already using MES to be competitive in the marketplace, it should.

MES is more than an application and this seminar gives the big picture on concepts and approaches necessary to achieve compliant MES systems in a timely manner within an integrated manufacturing environment. The seminar also previews the first edition of the GAMP® Good Practice Guide: Achieving Compliant Manufacturing Execution Systems (MES). Discussion and interactive activities will review:

  • Risk management as applied to MES;
  • Examples of real industry approaches and solutions;
  • Current industry perspectives on applications and approaches of GAMP applied to design, build, test, deployment of MES;
  • A regulatory view on integrated systems for manufacturing;
  • Insight as to how Product Quality Lifecycle Implementation (PQLI) aligns with GAMP 5 approaches; and
  • How GAMP MES aligns with GAMP 5.

Look for the article entitled Domain Methodology for Computer System Specification and Verification Applied to Manufacturing Execution Systems (MES) in the May/June issue of Pharmaceutical Engineering for an introduction to this important approach.

How You Will Benefit

At the conclusion of this session, participants will be able to:

  • Understand what MES are and their importance in manufacturing of drug and biotechnology products;
  • Explain the MES Domain; and
  • Apply MES approaches (based on GAMP 5 Principles) to maintaining a state of compliance throughout the operational lifetime of such systems.

Who Should Attend

MES practitioners and business leaders, quality assurance or compliance specialists, information technology professionals, engineers involved in specification and verification, anyone involved in implementing or supporting regulated systems, vendors, integrators, and consultants, research and development, or anyone specifying equipment or systems

Communities of Practice (COPs)

Good Automated Manufacturing Practice (GAMP), Commissioning and Qualification (C&Q), and Process Analytical Technology (PAT)

Related Technical Documents Available from ISPE - www.ISPE.org/publications

GAMP® 5

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